The Supplier Quality Engineer provides technical guidance and support to Novocure contract manufacturers and their suppliers in the areas of Medical Device Quality Assurance, Agreements, and Quality Control. This person ensures compliance to applicable regulatory requirements and procedures, while delivering to the objectives of applicable programs and strategic objectives. The Supplier Engineer Collaborates with business process owners and further develops product realization processes, ensuring stakeholder engagemect and an effective process framework facilitating rapid and cost effective delivery of safe and effective products.

Your responsibilities:

• Works with other members of the QA organization and Supply Chain to deliver against strategic goals and improvement plans
• Expands and improves the implementation of LEAN and Six Sigma methodologies both within Novocure and at its contract manufacturers and sub-tier suppliers.
• Acts and represents Supplier Quality as part of the Supplier Qualification process
• Ensure quality requirements are defined, implemented, maintained and monitored
• Acts as QA approver for contract manufacturer and sub-tier supplier test plans, process changes, tooling changes, and specifications
• Ensure that for any deviation reported by Novocure (audit, complaint, NCMRs, others), a SCAR is efficiently implemented by the Supplier. If needed, support the supplier in the definition of the SCAR.
• For critical suppliers, conduct Monthly Quality Meetings to monitor Quality KPIs .
• Ensure compliance to Novocure applicable requirements
• Report performance of the process during quarterly quality meetings or others
• Conducts or support suppliers audits
• Specifics
• Travel requirement: 20%

Your profile:

• Minimum of a Bachelor degree, preferably in a Science or Engineering discipline, with applied Quality Engineering experience of 3-5 years
• Supplier and QMS auditing experience in medical device, pharmaceutical or comparably regulated field
• ISO 13485 Certified Lead Auditor is preferred
• LEAN Certification or demonstrated experience applying LEAN and six sigma principles and methodologies.
• Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines.
• Practical experience with Quality Risk Management, product lifecycle management (PLM) and process validation.
• Fluent in English both written and spoken; any further languages are of benefit

Benefits:

Financial

• Performance related bonus
• Life Insurance

Lifestyle

• Free fruit & cookies delivered for office staff
• Multisport card

Health

• Private Medical care